Deferring the EU Agreement Two More Years

In a disappointing blow to industry, FDA and European regulators have extended the medical device annex of the U.S./EU mutual recognition agreement (MRA) transition period for two years. Once operational, the MRA will allow conformity assessment bodies (CABs) to conduct low-risk medical device reviews and quality systems–based inspections on behalf of the regulators.

"It is very disappointing that the MRA is not moving into an operational mode," National Electrical Manufacturers Association medical vice president Bob Britain commented.

The original three-year transition period was seen as a "confidence building" period after the MRA became effective on December 1, 1998. Both sides were to complete their verification of CABs that are to conduct low-risk medical device reviews and quality systems–based inspections on behalf of the regulators. So far, Britain said no CABs have been verified or "listed"; however, FDA indicated recently that four CABs may be listed early in 2002.

Britain says industry needs to step up its assistance in getting the CABs approved. In addition, before the MRA can become operational, the regulators need to agree on how many CABs should be listed. At this time, he says, both sides have not come to agreement on the minimum number of CABs needed to allow the MRA to proceed.

Once verified, FDA has suggested that the CABs could be allowed to begin performing independent 510(k) reviews and inspections—although the MRA won't become fully operational until both sides have approved CABs. However, many are skeptical that the MRA will ever come to fruition; they cite European preoccupation with a review of the European Medical Devices Directive and say the MRA with the U.S. doesn't have high priority.